IP Library Granted Patent US 10,238,867
Granted Patent B2
US 10,238,867 · App. 15/783,072 · Granted Mar 26, 2019

Pulsed electromagnetic field tissue stimulation treatment and compliance monitoring

Inventors: James T. Ryaby (Lewisville, TX); Mamak Monica Keramat (Lewisville, TX); Lesley Allen Bowling (Lewisville, TX); Bobby Don Harris (Lewisville, TX); James Sterling Denton (Lewisville, TX); Philip Hartley Garman (Lewisville, TX); Jeffrey James Culhane (Lewisville, TX); Jonelle Matilda Juricek (Lewisville, TX)
Assignee: Orthofix Inc.
A61N1/326A61N1/08A61N1/36003A61N1/36025A61N1/40A61N1/025A61N1/0476A61N1/37211A61N2/02
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Quick Facts
Patent No.
US 10,238,867
App. No.
15/783,072
Filed
Oct 13, 2017
Granted
Mar 26, 2019
Kind
B2
Art Unit
3791
USPC
600/14
Abstract

A system and method for PEMF tissue engineering enhances musculoskeletal tissue stimulation by monitoring treatment for compliance with treatment regimens. A PEMF device includes sensors that detect attributes indicating whether the PEMF device is in use. The PEMF device also includes communication devices that connect it with other devices. The data obtained from the sensors may be used to determine a level of compliance in use of the tissue engineering device with a prescribed treatment regimen for the patient. The data is transferred via a paired UE to a remote server. The remote server stores the data in a database and periodically generates compliance reports. The compliance reports are shared with subscribing access devices including the prescribing physician. The UE pairing with the PEMF device maintains a treatment calendar and dynamically modifies reminders based on current treatment status. The treatment regimen may be updated and sent to the PEMF device.

Claims (50)

1. A musculoskeletal tissue engineering and compliance monitoring system, comprising:

a tissue engineering apparatus comprising a coil device configured to supply a pulsed electromagnetic field (PEMF) to musculoskeletal tissue, wherein the tissue engineering apparatus is configured with a treatment regimen defining a periodic application of the PEMF over a long-term duration, the tissue engineering apparatus further comprising a sensor configured to detect use of the tissue engineering apparatus on the musculoskeletal tissue and a first transceiver configured to transmit data from the sensor;

a user equipment (UE) device comprising a second transceiver configured to associate with the tissue engineering apparatus and receive the data from the tissue engineering apparatus, and a UE processor configured to compare the data for compliance with the periodic application specified in the treatment regimen, generate a current status of the periodic application, and modify a treatment reminder based on the current status of the periodic application; and

a remote server comprising a third transceiver configured to receive the data including the current status from the UE device, and a server processor configured to compile the data into a compliance report identifying use of the tissue engineering apparatus over the long-term duration, the third transceiver further configured to transmit the compliance report to a subscribing device.

2. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein the UE processor is further configured to:

cause a display of the UE device to provide the treatment reminder according to the periodic application defined in the treatment regimen; and

determine whether the PEMF has already been supplied for a given periodic application over the long-term duration, and an extent of supply having already occurred for the given periodic application,

wherein the modification further comprises modifying the treatment reminder according to the extent determined for supply having already occurred for the given periodic application.

3. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein:

the tissue engineering apparatus further comprises an impedance monitor sensor,

the impedance monitor sensor is configured to detect a plurality of tissues including the musculoskeletal tissue, wherein the data corresponds to a stage of healing of the musculoskeletal tissue based on the detected plurality of tissues,

the tissue engineering apparatus is further configured to determine and display a level of compliance with respect to the treatment regimen, the data including the determined level of compliance, and

the first transceiver is further configured to transmit the data to the remote server for inclusion in the compliance report.

4. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein the server processor is further configured to:

aggregate the data received via the UE device from the tissue engineering apparatus during a period according to a periodic basis;

generate the compliance report at an end of the period; and

cause the remote server to provide a reminder about the treatment regimen based on a result of a comparison of data from the compliance report with the treatment regimen.

5. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein the subscribing device comprises a plurality of devices including the UE device and one or more computing devices configured to be associated with one or more physicians, the third transceiver further configured to transmit a notification to at least one of the plurality of devices that is based on the compliance report.

6. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein the periodic application is on a per-day basis, and the compliance report comprises:

a number of days that the tissue engineering apparatus has been in possession;

a breakdown of use of the tissue engineering apparatus per day for the number of days; and

a percentage of compliance based on the data and the treatment regimen.

7. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein the UE processor is further configured to:

receive, via a user interface of the UE, a pain scale value corresponding to a level of pain associated with a treatment site with the musculoskeletal tissue;

receive, via the user interface, an image of the treatment site; and

transmit the pain scale value and the image to the remote server for inclusion in the compliance report.

8. The musculoskeletal tissue engineering and compliance monitoring system of claim 1 , wherein:

the server processor is further configured to instruct, in response to the identifying the use of the tissue engineering apparatus over the long-term duration as deviating from the treatment regimen, the UE device to adjust one or more of a frequency of reminders, audible tones, verbal messages, text reminders, and interactive text-based messages until the deviating decreases below a threshold, and

the UE processor is further configured, based on the instruction, to adjust the one or more of the frequency of reminders, audible tones, verbal messages, text reminders, and interactive text-based messages.

9. An apparatus for musculoskeletal tissue engineering and compliance monitoring, comprising:

a tissue engineering device comprising a transducer coil configured to supply a pulsed electromagnetic field to musculoskeletal tissue;

a sensor configured to detect proximity of the tissue engineering device to the musculoskeletal tissue determined to correspond to application of the tissue engineering device to the musculoskeletal tissue;

a processor configured to poll the sensor for data identifying whether the tissue engineering device is in proximity and attributable to use of the apparatus with the musculoskeletal tissue; and

a transceiver configured to transmit the data to a separate device configured to determine compliance in using the apparatus according to a treatment regimen comprising a periodic activation over a defined number of applications, and to receive an update to the treatment regimen in response to the data being transmitted to the separate device and a remote server, based on a command provided by a computer device that is in communication with the remote server.

10. The apparatus of claim 9 , wherein:

the sensor comprises an accelerometer,

the poll comprises a first poll period having a first duration that is less than a duration of the periodic activation, wherein the accelerometer detecting motion during the first poll period indicates a first affirmative status of compliance for the first poll period, and

the data transmitted by the transceiver comprises the first affirmative status.

11. The apparatus of claim 10 , wherein:

the poll further comprises a second poll period having a second duration that is larger than and includes the first duration including a first plurality of first poll periods, and a third poll period having a third duration that is larger than, and includes, the second duration including a second plurality of first poll periods that includes the first plurality of first poll periods, the second and third durations being less than the duration of the periodic activation,

the accelerometer detecting motion during the second poll period for at least half of the first plurality of first poll periods, comprised in the second poll period, indicates a second affirmative status of compliance for the second poll period,

the accelerometer detecting motion during the third poll period for at least a quarter of the second plurality of first poll periods, comprised in the third poll period, indicates a third affirmative status of compliance for the third poll period, and

the data transmitted by the transceiver comprises the third affirmative status.

12. The apparatus of claim 9 , wherein the transceiver is further configured to receive a current time of day from the separate device after pairing with the separate device.

13. The apparatus of claim 9 , wherein the transceiver is further configured to transmit the data to the remote server via the separate device.

14. The apparatus of claim 13 , further comprising a display, wherein the processor is further configured to generate a compliance indication based on the data in comparison to the treatment regimen and to output the compliance indication on the display.

15. The apparatus of claim 9 , further comprising a healing monitor sensor, wherein:

the healing monitor sensor is configured to detect a plurality of tissues including the musculoskeletal tissue,

the processor is further configured to poll the healing monitor sensor for sensed data corresponding to the detected plurality of tissues, wherein the sensed data corresponds to a stage of healing of the musculoskeletal tissue, and

the transceiver is further configured to transmit the sensed data for inclusion in a compliance report that comprises the sensed data, a pain scale value, an image of a treatment site with the musculoskeletal tissue, and an activity level.

Assignments (11)
RELEASE OF SECURITY INTEREST Recorded Nov 12, 2024
From: BLUE TORCH FINANCE LLC
To: ISOTIS ORTHOBIOLOGICS, INC.; ORTHOFIX US, LLC; SEASPINE, INC.; SEASPINE ORTHOPEDICS CORPORATION; SPINAL KINETICS LLC; THEKEN SPINE, LLC
Reel/Frame 069358/0110 →
SECURITY INTEREST Recorded Nov 8, 2024
From: ORTHOFIX MEDICAL INC.; ORTHOFIX US LLC; SPINAL KINETICS LLC; SEASPINE ORTHOPEDICS CORPORATION; SEASPINE, INC.; ISOTIS ORTHOBIOLOGICS, INC.; THEKEN SPINE, LLC
To: OXFORD FINANCE LLC, AS AGENT
Reel/Frame 069332/0761 →
SECURITY INTEREST Recorded Jan 10, 2024
From: ORTHOFIX US LLC
To: BLUE TORCH FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 066256/0423 →
RELEASE OF SECURITY INTEREST Recorded Nov 16, 2023
From: JPMORGAN CHASE BANK, N.A.
To: ORTHOFIX US LLC
Reel/Frame 065609/0223 →
ENTITY CONVERSION Recorded Aug 19, 2021
From: ORTHOFIX INC.
To: ORTHOFIX US LLC
Reel/Frame 057247/0265 →
SECURITY INTEREST Recorded Apr 22, 2021
From: ORTHOFIX US LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE ASSISTANT
Reel/Frame 056000/0153 →
MERGER Recorded Jan 14, 2021
From: ORTHOFIX HOLDINGS, INC.
To: ORTHOFIX INC.
Reel/Frame 055002/0841 →
MERGER Recorded Jan 14, 2021
From: ORTHOFIX SPINAL IMPLANTS INC.
To: ORTHOFIX HOLDINGS, INC.
Reel/Frame 055002/0751 →
SECURITY INTEREST Recorded Oct 28, 2019
From: ORTHOFIX INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 050839/0155 →
SECURITY INTEREST Recorded Aug 29, 2018
From: ORTHOFIX INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 046747/0936 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 13, 2017
From: RYABY, JAMES T.; KERAMAT, MAMAK MONICA; BOWLING, LESLEY ALLEN; HARRIS, BOBBY DON; DENTON, JAMES STERLING; GARMAN, PHILIP HARTLEY; CULHANE, JEFFREY JAMES; JURICEK, JONELLE MATILDA
To: ORTHOFIX INC.
Reel/Frame 043858/0149 →
Continuity (2)
Provisional Application 62409014 · Oct 17, 2016
Related Publication 20180104484A1 · Apr 19, 2018
Cited By (2)
US 12,605,249 US 12,702,854